SAN DIEGO, July 29, 2015 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (NASDAQ:NBIX) today announced its financial
results for the quarter ended June 30,
2015. For the second quarter of 2015, the Company reported a
net loss of $24.0 million, or
$0.28 loss per share, compared to a
net loss of $13.4 million, or
$0.18 loss per share, for the same
period in 2014. For the six months ended June 30, 2015, the Company reported a net loss of
$25.2 million, or $0.30 loss per share, as compared to net loss of
$25.2 million, or $0.35 loss per share, for the first half of last
year.
The Company's balance sheet at June 30,
2015 reflected total assets of $511.2
million, including cash, cash equivalents, investments and
receivables of $501.5 million.
"During the first half of 2015 we have been focused on two
primary tasks, executing on our Phase III Kinect clinical trials
and beginning the commercial build for our VMAT2 inhibitor
NBI-98854," said Kevin Gorman,
Ph.D., President and Chief Executive Officer of Neurocrine
Biosciences. "To that end, we are nearing completion of
randomization in Kinect 3 while Kinect 4 continues its strong
enrollment. We made two key hires during the quarter:
Eric Benevich, formerly of Avanir,
joined as Chief Commercial Officer, and Bill Aurora, formerly of Merck, joined as Vice
President of Medical Affairs. They have initiated both the
commercial and medical outreach efforts that are crucial to the
success of our VMAT2 franchise. Additionally, the twelve month
dosing in the first elagolix endometriosis Phase III study has
completed and we and our partner AbbVie are very encouraged that
the efficacy and safety profile of elagolix at month twelve is
consistent with the positive month six results shared earlier this
year."
Research and development expenses were $18.7 million during the second quarter of 2015
compared to $10.2 million for the
same period in 2014. For the six months ended June 30, 2015, research and development expenses
were $35.3 million, compared to
$18.7 million for the same period
last year. This increase was primarily due to higher external
clinical development expenses and associated internal costs related
to NBI-98854, which initiated Phase III development in the second
half of 2014 and preparations for a potential New Drug Application
filing in 2016.
General and administrative expenses increased from $4.2 million for the second quarter of 2014 to
$6.6 million for the second quarter
of 2015. For the six months ended June 30,
2015, general and administrative expenses were $12.1 million, compared to $8.4 million for the first half of 2014. The
increase in general and administrative expense is primarily due to
higher personnel related costs, including a $1.5 million increase in year-to-date share-based
compensation expense. Additionally, professional costs related to
market research and pre-commercial activities contributed to the
overall increase in general and administrative expenses.
Pipeline Highlights
VMAT2 Update
In 2014, the Company initiated a Phase III study of NBI-98854,
the Kinect 3 study. The Kinect 3 study, along with the previous
efficacy studies of NBI-98854, is designed to complete the
placebo-controlled clinical efficacy evaluation of NBI-98854 in
tardive dyskinesia. The primary endpoint in the Kinect 3 study is
the mean change from baseline in the Abnormal Involuntary Movement
Scale as assessed by blinded central raters. The Kinect 3 study
includes approximately 240 subjects randomized to either placebo,
once daily 40mg of NBI-98854, or once daily 80mg of NBI-98854 for
six weeks of placebo-controlled dosing followed by an extension of
active dosing through Week 48. Top-line efficacy data from the
initial six weeks of placebo-controlled dosing is expected in the
second half of 2015.
A separate one-year open-label safety study of NBI-98854, Kinect
4, has also been initiated to support the anticipated 2016 filing
of a New Drug Application in tardive dyskinesia.
As announced previously, Neurocrine has also received
Breakthrough Therapy Designation from the FDA for NBI-98854 in the
treatment of tardive dyskinesia.
The Company is also exploring NBI-98854 in an initial Tourette
syndrome clinical trial, the T-Force study. This study is an
open-label, multi-dose, two-week evaluation of 36 subjects with
Tourette syndrome. Children and adolescents enrolled in the trial
are receiving a once-daily dose of NBI-98854 during a two-week
treatment period to assess both the safety and tolerability of
NBI-98854. Additionally, the Yale Global Tic Severity Scale and the
Premonitory Urge for Tics Scale are being utilized during the study
to assess the impact of NBI-98854 on the patients' Tourette
symptoms. Data read out from the T-Force study is expected in the
second half of 2015.
Elagolix Update
In early 2015, AbbVie announced positive top-line results from
the first of two ongoing Phase III clinical trials, the Violet
Petal Study, designed to evaluate the efficacy and safety of
elagolix in premenopausal women with endometriosis. Results from
the trial show that after six months of treatment, both doses of
elagolix (150 mg once daily and 200 mg twice daily) met the study's
co-primary endpoints (p<0.001) of reducing scores of
non-menstrual pelvic pain and menstrual pain (or dysmenorrhea)
associated with endometriosis at month three, as well as month six,
as measured by the Daily Assessment of Endometriosis Pain scale.
The observed safety profile of elagolix in the Violet Petal Study
was consistent with observations from prior studies. Among the most
common adverse events (AEs) were hot flush, headache, nausea and
fatigue. While most AEs were similar across treatment groups some,
such as hot flush and bone mineral density loss, were
dose-dependent. AbbVie recently completed the six month extension
of the initial elagolix Phase III endometriosis study and disclosed
that the efficacy and safety at month twelve were consistent with
the efficacy and safety findings seen at month six.
AbbVie is conducting the second Phase III study of elagolix for
endometriosis, the Solstice Study. This study is similar in design
to the Violet Petal Study and will assess 788 women, age 18 to 49,
with moderate to severe endometriosis-associated pain at more than
200 sites globally. Top-line efficacy data from this study is
expected in the first quarter of 2016.
Elagolix is also being evaluated in women with uterine fibroids.
AbbVie is conducting a Phase IIb clinical trial evaluating the
change in menstrual blood loss of 520 women, age 18-51, with heavy
menstrual bleeding associated with uterine fibroids. Patient
recruitment has been completed and top-line data from this study is
expected in the fall of 2015.
Conference Call and Webcast Today at 5:00PM Eastern Time
Neurocrine will hold a live conference call and webcast today at
5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). Participants can access
the live conference call by dialing 866-952-1906 (US) or
785-424-1825 (International) using the conference ID: NBIX. The
call can also be accessed via the webcast through the Company's
website at http://www.neurocrine.com.
If you are unable to attend the webcast and would like further
information on this announcement please contact the Investor
Relations Department at Neurocrine Biosciences at (858)
617-7600. A replay of the conference call will be available
approximately one hour after the conclusion of the call by dialing
800-695-2185 (US) or 402-530-9028 (International) using the
conference ID: NBIX. The call will be archived for one month.
Neurocrine Biosciences, Inc. discovers and develops innovative
and life-changing pharmaceuticals, in diseases with high unmet
medical needs, through its novel R&D platform, focused on
neurological and endocrine based diseases and disorders. The
Company's two lead late-stage clinical programs are elagolix, a
gonadotropin-releasing hormone antagonist for women's health that
is partnered with AbbVie Inc., and NBI-98854, a vesicular monoamine
transporter 2 inhibitor for the treatment of movement
disorders. Neurocrine intends to maintain certain commercial
rights to its VMAT2 inhibitor for evolution into a fully-integrated
pharmaceutical company.
Neurocrine Biosciences, Inc. news releases are available through
the Company's website via the internet at
http://www.neurocrine.com.
In addition to historical facts, this press release may
contain forward-looking statements that involve a number of risks
and uncertainties. Among the factors that could cause actual
results to differ materially from those indicated in the
forward-looking statements are risks and uncertainties associated
with Neurocrine's business and finances in general, as well as
risks and uncertainties associated with the Company's R & D
pipeline and the Company overall. Specifically, the risks and
uncertainties the Company faces include risks that clinical
development activities may not be completed on time or at all;
risks that clinical development activities may be delayed for
regulatory or other reasons, may not be successful or replicate
previous clinical trial results, may fail to demonstrate that our
product candidates are safe and effective, or may not be predictive
of real-world results or of results in subsequent clinical trials;
risks that regulatory submissions may not occur or be submitted in
a timely manner; risks that the Company's product candidates may
not obtain regulatory approval or that the U.S. Food and Drug
Administration or regulatory authorities outside the U.S. may make
adverse decisions regarding the Company's product candidates; risks
that the Company's product candidates may be precluded from
commercialization by the proprietary rights of third parties, or
have unintended side effects, adverse reactions or incidents of
misuse; risks associated with the Company's dependence on AbbVie
for elagolix development and commercialization and dependence on
other third parties for development, manufacturing and marketing
and sales activities; risks that the Company's research programs
will not identify pre-clinical candidates for further development;
risks that the Company will be unable to raise additional funding
required to complete development of all of its product candidates;
risk and uncertainties relating to competitive products and
technological changes that may limit demand for the Company's
products; and other risks described in the Company's annual report
on Form 10-K for the year ended December 31,
2014 and quarterly report on Form 10-Q for the quarter ended
March 31, 2015. Neurocrine disclaims
any obligation to update the statements contained in this press
release after the date hereof.
NEUROCRINE
BIOSCIENCES, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands,
except per share data)
(unaudited)
|
|
|
Three Months
Ended June 30,
|
Six Months
Ended June 30,
|
|
2015
|
2014
|
2015
|
2014
|
Revenues:
|
|
|
|
|
License
fees
|
$
-
|
$
-
|
$ 19,769
|
$
-
|
|
|
|
|
|
Total
revenues
|
-
|
-
|
19,769
|
-
|
Operating
expenses:
|
|
|
|
|
Research and
development
|
18,719
|
10,161
|
35,294
|
18,733
|
General and
administrative
|
6,603
|
4,200
|
12,085
|
8,353
|
|
|
|
|
|
Total operating
expenses
|
25,322
|
14,361
|
47,379
|
27,086
|
|
|
|
|
|
Loss from
operations
|
(25,322)
|
(14,361)
|
(27,610)
|
(27,086)
|
Other
income:
|
|
|
|
|
Gain (loss) on
sale/disposal of assets
|
-
|
5
|
9
|
(5)
|
Deferred gain on real
estate
|
829
|
805
|
1,659
|
1,609
|
Investment income,
net
|
506
|
167
|
763
|
256
|
Other income,
net
|
-
|
3
|
-
|
3
|
|
|
|
|
|
Total other
income
|
1,335
|
980
|
2,431
|
1,863
|
|
|
|
|
|
Net loss
|
$ (23,987)
|
$(13,381)
|
$ (25,179)
|
$ (25,223)
|
|
|
|
|
|
Net loss per common
share:
|
|
|
|
|
Basic and
diluted
|
$ (0.28)
|
$ (0.18)
|
$ (0.30)
|
$ (0.35)
|
|
|
|
|
|
Shares used in the
calculation of net loss per common share:
|
|
|
|
|
Basic and
diluted
|
85,518
|
75,879
|
82,947
|
73,085
|
|
|
|
|
|
|
|
NEUROCRINE
BIOSCIENCES, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(in
thousands)
(unaudited)
|
|
|
|
|
June
30, 2015
|
December 31, 2014
|
Cash, cash
equivalents and short-term marketable securities
|
$
384,720
|
$
193,809
|
Other current
assets
|
4,696
|
4,394
|
|
|
|
Total current
assets
|
389,416
|
198,203
|
Property and
equipment, net
|
2,802
|
2,507
|
Long-term
investments, available for sale
|
114,172
|
37,492
|
Restricted
cash
|
4,815
|
4,831
|
|
|
|
Total assets
|
$
511,205
|
$
243,033
|
|
|
|
|
|
|
Current
liabilities
|
$
17,553
|
$
15,664
|
Long-term
liabilities
|
26,712
|
18,670
|
Stockholders'
equity
|
466,940
|
208,699
|
|
|
|
Total liabilities and
stockholders' equity
|
$
511,205
|
$
243,033
|
|
|
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/neurocrine-biosciences-reports-second-quarter-2015-results-300120671.html
SOURCE Neurocrine Biosciences, Inc.